SPL Set ID: 3c28cf18-01a3-468a-ab3e-8aa82f918251

Olanzapine and Fluoxetine Capsules, USP combine an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine, USP (the active ingredient in Zyprexa ® , and Zyprexa ® Zydis ® ) and fluoxetine hydrochloride, USP (the active ingredient in Prozac ® and Sarafem ® ). Olanzapine, USP belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H -thieno[2,3- b ] [1,5]benzodiazepine. Fluoxetine hydrochloride, USP is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3-phenyl-3-[(α,α,α-trifluoro- p -tolyl)oxy]propylamine hydrochloride. The chemical structures are: C 17 H 20 N 4 S M.W. 312.44 C 17 H 18 F 3 NO•HCl M.W. 345.79 Olanzapine, USP is a pale yellow to yellow crystalline powder, which is practically insoluble in water. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Olanzapine and Fluoxetine Capsules, USP are available for oral administration in the following strength combinations: 3 mg/25 mg 6 mg/25 mg 6 mg/50 mg 12 mg/25 mg 12 mg/50 mg Olanzapine, USP 3 6 6 12 12 fluoxetine base equivalent 25 25 50 25 50 Each capsule also contains D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac glaze, and titanium dioxide. Additionally, the 3 mg/25 mg capsule contains D&C Yellow No. 10 and FD&C Yellow No. 6; both the 6 mg/25 mg and 12 mg/25 mg capsules contain ferric oxide yellow; the 6 mg/25 mg capsule contains ferric oxide red; and the 12 mg/50 mg capsule contains D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No. 40. olanzapine structure Fluoxetine Structure